All Boosters Now Approved - COVID-19 Update #106

• In September 2021, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow a booster dose, given at least six months after completion of the second dose to patients 65 years and older or who are at high risk for severe COVID-19, which includes healthcare professionals, frontline workers and people that live in group settings. The CDC agreed and also recommended a booster dose for these groups. 
• On 10/14/2021, the VRBAC voted 19 to 0 to recommend amending the EUA for the Moderna COVID-19 vaccine to include a booster dose of 50 mcg (100 mcg is used for the primary series) given at least 6-months after the primary series is completed in patients 65 or older or those 18 and older at high risk of severe COVID-19. The FDA agreed and amended the EUA for the Moderna COVID-19 Vaccine, on 10/20/2021, to allow a booster dose, given at least six months after completion of the second dose to patients 65 years and older or who are at high risk for severe COVID-19, which includes healthcare professionals, frontline workers and people that live in group settings. The approved booster dose if 50mcg, which is half the strength of the primary series dose.
• On 10/15/2021, the VRBAC voted 19 to 0 to recommend an amendment to the Johnson & Johnson COVID-19 vaccine EUA allowing a second immunization with the vaccine for all patients 18 and older at least two months after the initial injection. The FDA agreed and amended the EUA for the J&J COVID-19 Vaccine, on 10/20/2021, to allow a booster dose, given at least two months after completion of the second dose for all patients 18 and older at least two months after the initial injection.
• After discussing the J&J booster, the VRBAC discussed use of a different COVID-19 vaccine than a patient initially received, as a booster dose. A pre-print draft of a 29-day, 458 patient, Phase I/II, NIH-sponsored study found that a booster dose increased antibody titers for all combinations of vaccines received. The largest increase was in patients who had originally received the J&J vaccine and then received a booster dose with either mRNA vaccine. In the study the primary series dose of the Moderna vaccine (100 mcg) was used, while Moderna is requesting use of a 50 mcg dose for a booster. VRBAC was supportive of using an mRNA vaccine after an initial J&J vaccination but did not make a formal recommendation. However, the FDA expanded the EUA for all three approved vaccines on 10/20/2021 to allow any of the vaccines to be used as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.
• CDC’s ACIP unanimously (15-0) approved booster doses of the Moderna and J&J COVID-19 vaccines, on 10/21/2021, in line with the expanded EUA’s by the FDA. ACIP also endorsed use of any of the three approved vaccines as booster for eligible patients that have completed a primary series. The CDC formerly recommended booster doses for the Moderna and J&J COVID-19 vaccines, on 10/21/2021, as recommended by ACIP and approved by the FDA. CDC also agreed that any of the three approved vaccines can be used as booster for eligible patients that have completed a primary series with the same or one of the other vaccines. Booster doses with Moderna and J&J COVID-19 vaccines became available on 10/22/2021.